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Drug Facts
Distributed By
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Valumeds Ibuprofen (NDC 68210-0800). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, warnings, allergy alert, stomach bleeding warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed By
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Ibuprofen 200 mg (NSAID)
Pain reliever/fever reducer
Warnings
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
1-888-333-9792
VALUMEDS
*Compare to the active ingredient in
Advil®
IBUPROFEN
TABLETS USP,200MG
PAIN RELEIVER/
FEVER REDUCER
(NSAID)
100
TABLETS
(COATED BROWN)
* Please review the disclaimer below.